Effect of Teriparatide or Risedronate in Elderly Patients With a Recent Pertrochanteric Hip Fracture: Final Results of a 78-Week Randomized Clinical Trial

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F17%3A10366972" target="_blank" >RIV/00216208:11110/17:10366972 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00023728:_____/17:N0000035

Výsledek na webu

<a href="http://dx.doi.org/10.1002/jbmr.3067" target="_blank" >http://dx.doi.org/10.1002/jbmr.3067</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1002/jbmr.3067" target="_blank" >10.1002/jbmr.3067</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Effect of Teriparatide or Risedronate in Elderly Patients With a Recent Pertrochanteric Hip Fracture: Final Results of a 78-Week Randomized Clinical Trial

Popis výsledku v původním jazyce

We present final results of a study comparing teriparatide 20g every day (QD) with risedronate 35mg once per week (QW) started within 2 weeks after surgery for a pertrochanteric hip fracture. Patients with BMD T-score-2.0 and 25OHD 9.2ng/mL were randomized to receive 26-week double-dummy treatment plus calcium and vitamin D, followed by 52-week open-label treatment with the same assigned active drug. Primary endpoint was change from baseline in lumbar spine (LS) BMD at 78 weeks. Secondary and exploratory endpoints were change in BMD at the proximal femur, function, hip pain (Charnley score and 100mm Visual Analog Scale [VAS]), quality of life (Short Form-36), radiology outcomes, and safety. Data were analyzed with mixed models for repeated measures (MMRM) and logistic regression. Totally, 224 patients were randomized; 171 (teriparatide: 86) contributed to the efficacy analyses (mean +/- SD age: 77 +/- 7.7 years, 77% females). Mean baseline LS, femoral neck (FN), and total hip (TH) T-scores were -2.16, -2.63, and -2.51, respectively. At 78 weeks, BMD increased significantly more with teriparatide compared to risedronate at the LS (+11.08% versus +6.45%; p&lt;0.001) and FN (+1.96% versus -1.19%; p=0.003), with no significant between-group difference in TH BMD. Timed up-and-go (TUG) test was significantly faster with teriparatide at 6, 12, 18, and 26 weeks (differences: -3.2 to -5.9s; p=0.045 for overall difference). Hip pain during TUG test by 100mm VAS was significantly lower with teriparatide at 18 weeks (adjusted difference: -11.3mm, p=0.033; -10.0 and -9.3mm at 12 and 26 weeks, respectively; p=0.079 for overall difference). Other secondary and exploratory outcomes were not different. Teriparatide group showed two new hip fractures versus seven with risedronate (p=0.171) and more frequent hypercalcemia and hyperuricemia. In conclusion, 78-week treatment with teriparatide showed significantly greater increases in LS and FN BMD, less pain, and a faster TUG test versus risedronate. (c) 2016 American Society for Bone and Mineral Research.

Název v anglickém jazyce

Effect of Teriparatide or Risedronate in Elderly Patients With a Recent Pertrochanteric Hip Fracture: Final Results of a 78-Week Randomized Clinical Trial

Popis výsledku anglicky

We present final results of a study comparing teriparatide 20g every day (QD) with risedronate 35mg once per week (QW) started within 2 weeks after surgery for a pertrochanteric hip fracture. Patients with BMD T-score-2.0 and 25OHD 9.2ng/mL were randomized to receive 26-week double-dummy treatment plus calcium and vitamin D, followed by 52-week open-label treatment with the same assigned active drug. Primary endpoint was change from baseline in lumbar spine (LS) BMD at 78 weeks. Secondary and exploratory endpoints were change in BMD at the proximal femur, function, hip pain (Charnley score and 100mm Visual Analog Scale [VAS]), quality of life (Short Form-36), radiology outcomes, and safety. Data were analyzed with mixed models for repeated measures (MMRM) and logistic regression. Totally, 224 patients were randomized; 171 (teriparatide: 86) contributed to the efficacy analyses (mean +/- SD age: 77 +/- 7.7 years, 77% females). Mean baseline LS, femoral neck (FN), and total hip (TH) T-scores were -2.16, -2.63, and -2.51, respectively. At 78 weeks, BMD increased significantly more with teriparatide compared to risedronate at the LS (+11.08% versus +6.45%; p&lt;0.001) and FN (+1.96% versus -1.19%; p=0.003), with no significant between-group difference in TH BMD. Timed up-and-go (TUG) test was significantly faster with teriparatide at 6, 12, 18, and 26 weeks (differences: -3.2 to -5.9s; p=0.045 for overall difference). Hip pain during TUG test by 100mm VAS was significantly lower with teriparatide at 18 weeks (adjusted difference: -11.3mm, p=0.033; -10.0 and -9.3mm at 12 and 26 weeks, respectively; p=0.079 for overall difference). Other secondary and exploratory outcomes were not different. Teriparatide group showed two new hip fractures versus seven with risedronate (p=0.171) and more frequent hypercalcemia and hyperuricemia. In conclusion, 78-week treatment with teriparatide showed significantly greater increases in LS and FN BMD, less pain, and a faster TUG test versus risedronate. (c) 2016 American Society for Bone and Mineral Research.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30226 - Rheumatology

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2017

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of Bone and Mineral Research

ISSN

0884-0431

e-ISSN

—

Svazek periodika

32

Číslo periodika v rámci svazku

5

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

12

Strana od-do

1040-1051

Kód UT WoS článku

000400590900017

EID výsledku v databázi Scopus

2-s2.0-85018444254